FDA grants fast track designation to Axovant's nelotanserin for visual hallucinations in dementia with Lewy bodies

Axovant Sciences

19 June 2017 - Axovant Sciences today announced that the U.S. FDA has granted fast track designation to its investigational drug nelotanserin for the treatment of visual hallucinations disorder in dementia with Lewy bodies.

Nelotanserin is a novel 5HT2A inverse agonist being investigated in a Phase 2 double-blind, randomised, placebo-controlled crossover safety study involving more than 20 subjects diagnosed with Lewy body dementia who experience frequent visual hallucinations. In addition, nelotanserin is being investigated in a Phase 2 double-blind, randomised, placebo-controlled study involving up to 60 subjects diagnosed with Lewy body dementia who have REM sleep disorder.

Read Axovant Sciences press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission , Fast track